Method of reducing rigidity of angioplasty balloon sections

ABSTRACT

A dilatation balloon is fabricated according to a process that forms cavities and indentations in the balloon and/or catheter sections. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser or another type of laser or mechanical material removal tool is used to remove the polymeric material, virtually without thermal effects. Cavities in the sleeve sections of the balloon are defined and if desired, indentations in the cone sections are defined. Material removal, particularly near the balloon sleeves enables a thinner, more flexible bonding area between the catheter shaft and the balloon. Further, the indentations along the cone sections enables tighter wrapping of the balloon for a reduced delivery profile. Rigidity near the sleeves is reduced for better maneuverability of the catheter in tortuous passageways.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Divisional of application Ser. No. 11/455,382,filed Jun. 19, 2006 now U.S. Pat. No. 7,967,836, which claims thebenefit of U.S. Provisional Patent Application Ser. No. 60/692,920,filed Jun. 17, 2005, each of which are incorporated herein in theirentirety by reference thereto.

FIELD OF THE INVENTION

The present invention relates generally to dilatation balloon cathetersand systems used for expansion against an obstruction within a bodyvessel or channel, or to deliver devices such as, but not limited to,intravascular stents and therapeutic agents to sites within vascular ortubular channel systems of the body. Particularly, the invention relatesto a dilatation balloon catheter and system having an improveddilatation balloon. The dilatation balloon has improved pliability,trackability and maneuverability in the passages of the vascular system.

BACKGROUND OF THE INVENTION

The present invention relates to dilatation balloon catheters employedin applications such as percutaneous transluminal angioplasty (PTA) andpercutaneous transluminal coronary angioplasty (PTCA) procedures, andmore particularly to enhancements to such catheters and their dilatationballoons for improved maneuverability in smaller and more tortuouspassages of the vascular system.

Dilatation balloon catheters are well known for their utility intreating the build-up of plaque and other occlusions in blood vessels.Typically a catheter is used to carry a dilatation balloon to atreatment site, where fluid under pressure is supplied to the balloon,to expand the balloon against an obstruction. Additionally, theexpansion of the balloon may deploy a stent device in the treatmentarea.

The dilatation balloon is typically mounted along the distal portion,e.g., distal end region, of the catheter and coaxially surrounds thecatheter shaft. Upon expansion of the dilatation balloon, the main bodyportion or medial section, of the balloon, sometimes referred to as theworking portion, increases to define a diameter which is substantiallylarger than the diameter of the catheter shaft. Proximal and distalsleeves or stems of the balloon have diameters substantially equal tothe diameter of the catheter. Proximal and distal tapered sections, orcones, join the medial region to the proximal and distal shafts,respectively. Each cone diverges in the direction toward the medialregion. Bonds between the balloon and catheter form a fluid tight sealto facilitate dilatation of the balloon by introduction of a fluid underpressure.

Along with body tissue compatibility, primary attributes considered inthe design and fabrication of dilatation balloons are strength andpliability. A higher hoop strength or burst pressure generally reducesthe risk of accidental rupture of a balloon during dilatation, althoughthis is also dependent on the characteristics of the vessel lesion.

Pliability refers to formability into different shapes, rather thanelasticity. In particular, when the balloon is an uninflatedconfiguration, the dilatation balloon is evacuated, flattened andgenerally wrapped circumferentially about the catheter distal region.Thin, pliable dilatation balloon walls facilitate a tighter wrap thatminimizes the combined diameter of the catheter and balloon duringdelivery. Furthermore, pliable balloon walls enhance the catheter“trackability” in the distal region, i.e. the capability to bend inconforming to the curvature in vascular passages.

One method of forming a strong and pliable dilatation balloon ofpolyethyleneterephthalate (PET) is disclosed in U.S. Pat. No. Re. 33,561(Levy). A tubing of PET is heated at least to its second ordertransition temperature, then drawn to at least triple its originallength to axially orient the tubing. The axially orientated tubing isthen radially expanded within a cylindrical form, to a diameter at leasttriple the original diameter of the tubing. The form defines theaforementioned main body, shafts and cones, and the resulting balloonhas a burst pressure of greater than 200 psi.

Such balloons generally have a gradient in wall thickness along thecones. In particular, dilatation balloons with an expansion diameter inthe range of 3.0-4.0 mm tend to have a wall thickness along the mainbody in the range of 0.0004-0.0008 inches (0.010-0.020 mm). Near themain body, the cones have approximately the same wall thickness.However, the wall thickness diverges in the direction away from the mainbody, until the wall thickness near each shaft is in the range of0.001-0.0025 inches (0.025-0.063 mm). Smaller dilatation balloons(1.5-2.5 mm) exhibit the same divergence in the cone walls, i.e. from0.0004-0.0008 inches near the main body to 0.0008-0.0015 inches(0.02-0.04 mm) near the associated shaft or stem.

The increased wall thickness near the stems does not contribute toballoon hoop strength, which is determined by the wall thickness alongthe balloon medial region. Thicker walls near the stems reducemaneuverability of the balloon and catheter. The dilatation ballooncannot be as tightly wrapped, meaning its delivery profile is larger,limiting the capacity of the catheter and balloon for treatingocclusions in smaller vessels.

U.S. Pat. No. 4,963,133 (Noddin) discloses an alternative approach toforming a PET dilatation balloon, in which a length of PET tubing isheated locally at opposite ends and subjected to axial drawing, to formtwo “necked down” portions which eventually become the opposite ends ofthe completed balloon. The necked down tubing is simultaneously axiallydrawn and radially expanded with a gas. The degree to which the tubingends are necked down is said to provide control over the ultimate wallthickness along the tapered walls (or cones), so that the wall thicknesscan be equal to or less than the wall thickness along the main body.This approach, however, is said to result in a comparatively low burstpressure, only about 8 atmospheres, or about 118 psi.

Typically, the balloon is secured to an elongate member of the cathetershaft. In this manner, the proximal and distal sleeves of the balloon issecured for example, heat welded to a catheter shaft. The bonded area ofthe balloon often gets stiffer and larger in diameter after bonding tothe catheter shaft. This is partly due to material accumulation, and tocrystallization of the polymer material of the balloon.

Therefore, it is an object of the present invention to provide adilatation balloon having a high burst pressure, high hoop strength,good folding characteristics, and good trackability.

A further object is to provide a balloon with portions of the balloonwall selectively thinned to enable a tighter wrapping of the ballooncircumferentially about a catheter distal end region, for a reducedprofile during balloon delivery.

Yet another object is to provide a process for selectively removingmaterial from a balloon catheter and its dilatation balloon, to enhancecatheter trackability and maneuverability without crystallization,embrittlement or other thermal degradation of material. This selectiveremoval of material may be achieved through the use of an excimer laser.This selective removal of material may also be achieved through the useof a phemto-second laser, or any other laser source that is capable ofmaterial removal. This selective removal of material may also beachieved through the use of a mechanical process such as drilling,milling, blasting, etching, or grinding.

SUMMARY OF THE INVENTION

The purpose and advantages of the present invention will be set forth inand apparent from the description that follows, as well as will belearned from the practice of the invention. Additional advantages of theinvention will be realized and attained by the methods and systemsparticularly pointed out in the written description and claims hereof,as well as from the appending drawings.

To achieve these and other advantages, and in accordance with thepurpose of the invention, as embodied herein and broadly described, theinvention includes a dilatation balloon having a tapered region such asproximal and distal cone sections and a working or medial sectiondisposed therebetween. The medical balloon further includes a mountingregion such as proximal and distal sleeve sections disposed proximatethe proximal and distal cones, respectively.

The mounting region is adapted for fluid tight bonding to a catheter orother delivery device. The dilatation balloon medial or working regionis substantially larger in diameter than the mounting region and isadapted to engage tissue at a treatment site responsive to expansion ofthe dilatation balloon, or to expand a stent device within a treatmentsite. The balloon tapered region or cone sections between the working ormedial region and the mounting region diverges in the direction from themounting region toward the working region. This section may also bestepped, have a non-circular cross-section, or be otherwise reduced indiameter from the working region to the mounting region.

In one aspect of the invention, the expandable balloon includes at leastone cavity disposed along the proximal or distal sleeve sections. Inanother aspect of the invention, the balloon includes at least oneindentation along the length of proximal or distal cone sections of theballoon and indentations in the cone sections of the balloon. In thismanner, the balloon can be fabricated according to a process thatincludes: directing a laser beam onto a biaxially oriented balloon at aselected location along an exterior surface of the balloon to ablativelyremove material therefrom. Alternatively, a variety of known techniquesother than ablation, for example, milling, grinding and other suitableknown techniques can be used to form the cavities or indentations inaccordance with the present invention.

Further, the at least one cavity and/or the at least one indentation caninclude a plurality of cavities and/or plurality of indentationsrandomly dispersed along the balloon sections or dispersed in a specificpattern along the balloon sections.

In one embodiment, the wall thickness of the tapered portion havingundergone the ablative process is substantially equal to the nominalwall thickness of the medial working section of the balloon.Alternatively the tapered sections may have thicknesses greater or lessthan the nominal wall thickness of the balloon. In either event, theindentations are configured to increase balloon maneuverability andpliability by reducing balloon wall stiffness near the mountingsections, and allows a tighter wrapping of the balloon for a reduceddelivery profile.

Thus in accordance with the present invention, polymeric material isremoved from catheters and dilatation balloons by selective excimerlaser ablation, phemto-second laser milling, the use of any other lasersource that enables material ablation, or mechanical processes to reducedilatation balloon wrapping profiles and increase flexibility in theballoon and catheter for accommodating curvature in arterial passagewaysand other body cavities. The improvements are achieved while maintaininga balloon burst pressure above 8 atm.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the invention claimed.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide furtherunderstanding of the method and system of the invention. Together withthe description, the drawings serve to explain the principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a further appreciation of the above and other advantages, referenceis made to the following detailed description and to the drawings, inwhich:

FIG. 1 is a partial plan view of the distal end of the dilation ballooncatheter in accordance with the present invention;

FIG. 2 is a partial plan view of one embodiment of a balloon having atleast one cavity in accordance with the invention;

FIG. 3 is a partial plan view of a balloon having at least one cavityextending from the edge of the balloon sleeve in accordance with theinvention;

FIG. 4 is a partial plan view of balloon having a spirally shaped cavityalong a length of the balloon sleeve in accordance with the invention;

FIG. 5 is the balloon of FIG. 2 bonded to a catheter shaft in accordancewith the invention;

FIG. 6 is a partial cross-sectional view of the distal end of thedilation balloon described herein, wherein indentations have been formedwithin a portion of the balloon in accordance with the presentinvention;

FIGS. 7 and 8 are end views of exemplary embodiments of dilationballoons fabricated in accordance with the present invention;

FIG. 9 illustrates a method of forming indentations using an excimerlaser and a mask element;

FIG. 10 illustrates a method of forming indentations in balloon materialby using a series of mirrors and lenses to direct the laser energy tothe balloon surface;

FIG. 11 illustrates a method of forming indentations in balloon materialusing a mechanical tool such as a grinding tool where indentation depthis controlled by tool displacement;

FIG. 12 illustrates a method of forming indentations in balloon materialusing a mechanical tool and a mechanical stop to limit travel of thegrinding tool within the balloon material; and

FIG. 13 illustrates a method of forming indentations in balloon materialusing a mechanical tool and a pressure sensitive mechanism to controltravel of the grinding tool with the balloon material.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present invention will be described with reference to a fewspecific embodiments, the description is illustrative of the inventionand is not to be construed as limiting the invention. Variousmodifications to the present invention can be made to the preferredembodiments by those skilled in the art without departing from the truespirit and scope of the invention as defined by the appended claims. Itwill be noted here that for a better understanding, like components aredesignated by like reference numerals throughout the various figures.

In one aspect of the present invention, a medical device is provided.The medical device generally comprises an elongated shaft member havinga proximal end and a distal end. The elongated shaft member furtherincludes a guidewire lumen and an inflation lumen extending along alength thereof. Further, an expandable member such as a balloon isdisposed proximate the distal end of the shaft. The expandable member isin fluid communication with the inflation lumen extending along theelongated shaft member.

Referring now to FIG. 1, the expandable medical device 100 in accordancewith the present invention is shown. In accordance with the invention,the medical device 100 includes a catheter shaft 30 having a proximalend 32 and a distal end 34. An inflation lumen 38 is disposed within theelongate catheter shaft 30. Further, the catheter shaft 30 includes aguidewire lumen (not shown) extending along a length of the cathetershaft 30. In one embodiment, the guidewire lumen can be disposed withinthe elongate shaft 30 between the proximal end 32 and the distal end 34to define an over-the-wire catheter. Alternatively, the guidewire lumencan be disposed at least in the proximal section of catheter shaft 30 todefine a rapid exchange catheter system, if desired. Further, theguidewire lumen can be configured to define a coaxial or a side-by-sidearrangement with catheter shaft 30.

A balloon 10 is disposed proximate the distal end 34 of the shaft 30.The inflation lumen 38 is in fluid communication with an interior of theballoon and the proximal end 32 of the shaft 30. The shaft 30 furtherincludes a hub (not shown) disposed on the proximal end 32. The hubpreferably includes two lumens, a first lumen in communication with theguidewire lumen and the second in communication with the inflationlumen. A central axis extends through the balloon 10, wherein thesections of the balloon as described above are radially disposed aboutthe axis, thereby forming a balloon having generally cylindrical andconical shapes. The balloon 10 is sealed in a fluid tight manner aboutthe catheter shaft 30 and in fluid communication with the inflationlumen 38 of the catheter shaft 30. When fluid is introduced into theinflation lumen, the balloon expands about a central axis of the shaft30.

In accordance with the invention, a medical device such as anendoprosthesis (not shown) can be disposed radially about the balloon10, wherein expansion of the balloon permits deployment of theendoprosthesis. Exemplary endoprosthesis' are shown and described inco-pending U.S. patent application Ser. No. 10/430,636 entitled“Endoprosthesis For Controlled Contraction and Expansion” and U.S.patent application Ser. No. 10/430,644 entitled “Endoprosthesis HavingFoot Extensions” the entireties of which are herein incorporated byreference.

The catheter shaft 30 may be constructed from a variety of suitablematerials or a combination of suitable materials. For example, the shaft30 can be constructed of polymer materials including nylon, polyimide,Pebax or metallic materials including stainless steel, nitinol and otheralloys. Further, the proximal section of the catheter shaft may formedfrom a material different than the distal section of the catheterdepending on the intended application of the medical device 100. Forexample, the proximal section of the catheter can be formed from avariety of materials including but not limited to metal, metal alloy,carbon, carbon reinforced materials, metal reinforced polymers, boronfiber reinforced materials, glass reinforced materials, aramid fiberreinforced materials, ceramic, composite, Kevlar, or polymer. The distalsection of the shaft 30 may be formed of but not limited to polyamide,PEEK, PTFE, PVDF, PEBAX®, polyimide, polyester, polyurethane, liquidcrystal polymer, or polyethylene of various suitable densities.

A suitable example of a catheter shaft construction is shown anddescribed in co-pending U.S. Patent Applications entitled “CatheterHaving Coil-Defined Guidewire Passage” having application Ser. No.11/136,251 filed May 24, 2005; “Catheter Having First and SecondGuidewire Tubes And Overlapping Stiffening Members” having applicationSer. No. 11/136,640 filed May 24, 2005 and U.S. Provisional PatentApplications entitled “Multiple Lumen Catheter and Method of MakingSame” having application Ser. No. 60/684,143, filed May 24, 2005;“Catheter Having Plurality of Stiffening Members” having applicationSer. No. 60/684,135 filed May 24, 2005. The entire contents of each ofwhich are incorporated herein by reference.

In accordance with the invention, and as shown in FIG. 1, balloon 10includes proximal cone section 15, a distal cone section 14 and a medialsection extending therebetween 16. The balloon further includes aproximal sleeve section 13 and a distal sleeve section 12 disposedproximate proximal and distal cone sections, respectively. The balloonis preferably made of polymeric material such as nylon or Pebax.Alternatively, however, other materials can be used as desired.

The balloon 10 is fabricated using techniques known in the art. Forexample and not limitation, the balloon may be fabricated by thisprocess including the steps of a) axially drawing a length of polymerictubing to substantially elongate a length of the tubing while heatingthe tubing to a temperature above its second order transitiontemperature, to axially orient the tubing; b) radially expanding thetubing to substantially increase the diameter along at least a portionof the tubing length while maintaining the tubing above the second ordertransition temperature, to radially orient the tubing, thus to form abiaxially oriented balloon with a medial section having a nominaldiameter and a nominal wall thickness, proximal and distal end mountingsections and proximal and distal tapered sections between the medialsection and the proximal and distal end mounting sections respectively;c) allowing the biaxially oriented balloon to cool below the secondorder transition temperature. However, other suitable methods of forminga balloon can be used, as would be known in the art.

In accordance with one aspect of the invention, and as depicted in FIG.2, the balloon proximal or distal sleeve sections 12, 13 includes atleast one cavity 22 formed in the wall of the sleeve sections.Preferably, the at least one cavity 22 is a plurality of cavities formedin the wall of at least one of the proximal or distal sleeve sections12, 13.

The wall of the sleeve includes a first surface 12 a and a secondsurface 12 b. For example, the first surface can be the outer surface ofthe sleeve section and the second surface can be the inner surface ofthe sleeve section. The at least one cavity includes a cut extendingthrough at least one of the first or second surfaces of the wall of thesleeve section. For example, the cavity can include a cut which extendsthrough both the first and second sleeve sections. In this manner, ahole or opening is defined through the wall of the sleeve section.Alternatively, however, the cavity can include a cut which only extendsthrough one of the first or second surfaces. For example and notlimitation, the cut can extend through an outer surface of the wall ofthe sleeve section but not penetrate through the inner surface of thewall of the sleeve section. In this manner, a pitted area is defined inthe wall of the sleeve section. The pitted area preferably has asufficient depth extending in the wall of the sleeve to collect flowingpolymer material from the balloon during bonding to a catheter shaft, aswill be discussed below.

The cavity 22 defined in the wall of the distal or proximal sleevesections is formed by the removal of material from the sleeve section. Avariety of techniques can be used for removing the material from theproximal or distal sleeve section to define the cavity. For example butnot limitation, the cavity can be formed by at least one techniqueincluding laser ablation, mechanical grinding, milling, blasting,drilling, chemical or mechanical etching and any combination thereof.However, any suitable method can be used to remove the material, aswould be known in the art. Alternatively, for example, the balloonincluding at least one cavity in the wall of the sleeve section can beformed by use of a mold or other device, such as a die.

In accordance with one embodiment of the invention, as shown in FIG. 2,the sleeve section 12 includes a plurality of cavities 22 that arescattered or randomly disposed about a length of the sleeve section. Inthis regard, the length could be the circumferential length of thesleeve section, the longitudinal length of the sleeve section or both.Alternatively, the plurality of cavities can be disposed in apredetermined pattern along the circumferential or longitudinal lengthof the sleeve section, as shown in FIGS. 3 and 4.

In another embodiment of the invention, as depicted in FIG. 3, the atleast one cavity includes at least one cut extending from an edge of theproximal or distal sleeve section along the longitudinal length thereof.Further and as shown in FIG. 3, a plurality of cuts can be disposedabout the circumferential length of the sleeve section to define aplurality of cavities.

In yet another embodiment of the invention, the cavity can be configuredto define a spiral or helical cut circumferentially about the proximalor distal sleeve section, as shown in FIG. 4. In this manner,preferably, the cavity extends through only one of the first or secondsurfaces of the wall of the sleeve section. In this manner, the cavitydefines a pitted area in the wall of the sleeve section.

In accordance with various embodiments of the invention, as depicted inFIGS. 2, 3 and 4, a cavity can be defined as a circular shapedstructure, a triangular shaped structure, or a spiral or helical shapedstructure. Alternatively, the at least one cavity can be configured todefine other suitable shapes including but not limited to a star shape,polygonal shape or sinusoidal shape for example but not limitation.

As discussed the at least one cavity can include a plurality ofcavities, the depth of the cavities may be constant or varied, asdesired. For example, the plurality of cavities can include cavitieshaving the same or different depths relative to one another and relativeto the thickness of the wall of the proximal or sleeve sections. In thisregard, the depth of the cavity defined in the wall of the proximal ordistal sleeve section should be sufficient to receive molten polymermaterial from the sleeve section during bonding to a catheter shaft. Inthis regard, the proximal and/or distal sleeve sections are configuredto define a bonding area which provides a reduced bonding profile whenbonded to the catheter shaft.

Accordingly, in yet another embodiment of the present invention acatheter having a reduced bonding profile is provided, as depicted inFIG. 5. The catheter includes an elongate shaft member 30 having aproximal section and a distal section and a length therebetween. Theballoon 10 in accordance with the invention is bonded to the distalsection of the catheter. During the bonding process, the polymericmaterial of the balloon becomes molten and flows into the cavitiesdefined in the wall of the proximal and distal sleeve sections. In thisaspect of the invention, the reduced bonding profile 8 is defined by themolten polymeric material from the proximal and/or distal sleeve sectionflowing into the at least one cavity. Accordingly, a thinner and moreflexible bond is achieved due to the reduction in the amount of materialat the bonding area. In one embodiment of the invention, the cavitiesare entirely filled with the flowing polymer such that the cavities areno longer visible after the balloon is bonded to the shaft.

In another aspect of the invention, referring now to FIG. 6, there isshown a partial cross-sectional view of the balloon 10, wherein theballoon 10 is shown in an expanded state. The balloon further comprisesat least one indentation 24 disposed along a length of the proximaland/or distal cone sections 14, 15. The proximal and distal conesections 14, 15 each include a wall having a first thickness 26. Themedial or working section of the balloon includes a wall having a secondthickness 28. The at least one indentation 24 includes a depth 26 aextending into the wall or thickness 26 of the proximal and/or distalcone sections 14, 15 to define a third reduced thickness 26 b along asection of the proximal or distal cone sections.

In one embodiment, the reduced thickness 26 b defined by the indentationin the wall of the cone section is not less than the thickness of thewall of the medial section 28 of the balloon, as schematically shown inFIG. 6. For example and not limitation, the reduced thickness 26 bdefined by the depth 26 a of the indentation 24 is substantially equalto the thickness 28 of the wall of the medial section 16.

The wall thickness 26 of the cone section 15 is shown to beapproximately twice the wall thickness 28 of the medial or workingsection 16 of the balloon. Although certain wall thicknesses are shownand described herein, they should not be considered limiting in anymanner and are merely provided for exemplary purposes. In this example,the depth of the indentations 24, i.e. the distance from the bottom ofthe indentation to the inner surface of the cone section 15, issubstantially equal to the wall thickness 28 of the medial or workingsection 16. It shall be understood that this is an example, and therelative wall thicknesses of these sections may vary. The dimensions forthe indentations 24 may also vary due to manufacturing tolerances.

As with the at least one cavity described above, the at least oneindentation is formed by at least one technique selected from the groupconsisting of laser ablation, mechanical grinding, milling, blasting,drilling, chemical or mechanical etching and any combination thereof.However, other suitable techniques can be used.

In this aspect of the invention, the balloon 10 in accordance with thepresent invention can be folded to a smaller effective diameter thanballoons not manufactured according to the teachings of the presentinvention. The indentations 24 are configured to reduce the stiffness ofthe cone sections 14, 15. This reduction in stiffness results in a morepliable balloon that can be wrapped tighter about the diameter of thecatheter, which leads to a lower crossing profile. The indentations 24also reduce the average wall thickness of the cone sections 14, 15.Therefore, the medical device 100 in accordance with the presentinvention is capable of being inserted into smaller body vessels andtubular channels than similar medical devices.

Further, the medical device 100 illustrated in the partialcross-sectional view of FIG. 1 exhibits better trackability thanpresently available medical devices. The improved trackability is due tothe indentations which are formed on the cone sections 14, 15 of theballoon 10, as shown in FIG. 6. The indentations 24 reduce the stiffnessof the balloon 10. The reduced stiffness leads to improved flexibilityof the balloon 10 and therefore the medical device 100. The increasedflexibility allows the medical device 10 to conform more easily to thetortuous vascular passages that it passes, or tracks, through.Additionally, since the average stiffness of the affected balloonsections are lower, they will conform more easily to the vessel duringexpansion, which has benefit in terms of reducing trauma to the bodyvessels or tubular channels. Further, the reduced profile bonds achievedby the at least one cavity defined in the proximal and/or distalsections of the sleeve sections contributes to the advantages of thecatheter such as flexibility and lower profile, as discussed above.

In accordance with the present invention, referring now to FIG. 7, thereis shown an end view of an exemplary embodiment of proximal cone section15 including a plurality of indentations 24 formed along a lengththereof. As shown in FIG. 7, the indentations 24 are represented ashaving a generally circular shape. The depth and diameter of theseindentations 24 may be constant or varied relative another indentationand relative to the wall of the cone section. Additionally, although thepattern of indentations 24 formed on the cone sections 14, 15 depictedin FIG. 7 is semi-uniform, this should not be considered limiting in anymanner. It is contemplated that the indentations 24 may be disposed onthe proximal or distal cone sections 14, 15 utilizing randomdistribution or specific patterns. For example, and as depicted in FIG.8, an alternative embodiment includes a plurality of indentations 24disposed in a specific and predetermined pattern in the wall of the conesection 15. For the purpose of illustration and not limitation, theindentations 24 are patterned in a uniformly spaced series disposed in aradial direction.

Further, as shown in FIG. 8, the indentations 24 in accordance with thealternative embodiment have a generally square shape. As previouslydescribed, the indentations 24 may be formed having other geometricfeatures, such as polygonal shapes including triangular, circular,pentagonal, star-shaped, or other similar geometries, or any combinationthereof. Further, the indentations can be formed to have a linear orsinusoidal shape, if desired, including but not limited to spiral path,linear path, circular rings, or disposed in completely randomizedlocations. Further still, the indentations 24 disposed on the conesections of the balloon can include one or more geometric patterns thatmay be in accordance with the present invention.

As discussed, the indentations 24 or the cavities 22 described herein inaccordance with the present invention can be formed in the balloon 10using a variety of processes. In one embodiment, it is contemplated thata laser source may be used to ablate material in the desired areas toform the indentations 24 or cavities 2.

Referring now to FIGS. 9 and 10, there is shown an exemplary embodimentof a method of forming the indentations 24. As noted, the followingdiscussion of the processes of forming the indentations 24 in the conesections of the balloon is equally applicable to forming the cavities 22in the proximal or distal sleeve sections of the balloon.

As depicted in FIG. 9, an excimer laser is utilized. As shown in FIG. 9,the head 40 of the excimer laser is positioned so that a beam 42 isapproximately perpendicular to the cone section 14, 15 of the balloon 10where it is desired to form indentations 24 therein. A mask 44 is usedto define the location where material will be ablated from the balloon.After a pulse or series of pulses has been emitted by the laser toablate an indentation or series of indentations as defined by the mask,the balloon may be rotatably indexed to a new position. Another pulse orseries of pulses may then be emitted to form a new indentation or seriesof indentations in the balloon material. This process may be repeateduntil the desired field of indentations is achieved.

In another aspect of the invention, referring now to FIG. 10, there isshown an alternative method in accordance with the present invention forforming the indentations 24 within the cone sections 14, 15 of theballoon 10. As shown in FIG. 10, a series of lenses and/or mirrors maybe used in conjunction with, or without, a mask, to direct the laserbeams to the balloon surface, so that the laser and balloon surface canbe positioned differently. In addition, a phemto-second laser or anylaser capable of material removal may be used in accordance with themethods of the present invention in combination in addition to or as analternative to the excimer laser.

Referring now to FIG. 11, there is shown yet another method of formingthe indentations 24 in the cone section of the balloon 10 in accordancewith the present invention. As shown in FIG. 11, the indentations 24 maybe formed in the cone section 14, 15 of the balloon 10 through agrinding process. It is contemplated that the grinding process utilizedto form the indentations can be embodied in many different manners. Forexample, one such method is shown in FIG. 11. In accordance with thisalternative process the balloon 10 is expanded and fixed to a mandrel.For example, wherein a grinding tool 50 located approximatelyperpendicular to the balloon surface and is advanced toward the conesections 14, 15 of the balloon 10. The relative position of the grindingtool and the balloon can then be changed, for example, by rotating theballoon and translating the cutting tool. The process may be repeated toachieve the desired grouping of indentations.

Alternatively, the process may be performed by fixing the grinding tooland displacing the expanded balloon. In addition to using a grindingtool, any other mechanical tool used for removing material may be used,for example but not limited to, drill bits, ultrasonic tools, and fluidjets.

Referring now to FIG. 12, there is illustrated yet another alternativeembodiment of a process in accordance with the methods of the presentinvention. As shown in FIG. 12, the expanded balloon 10 may be pressedagainst a mask 52. This mask could be, for example, a material shim thathas a hole cut in it. The diameter of the hole would closely match thediameter of the tool being used to remove the balloon material. With themask pressed against the balloon surface on one side, the tool may thenbe inserted through the mask hole on the other side, movingapproximately perpendicular to the balloon surface. The cutting toolwould have a stop configured to contact the mask, thereby allowing thetool to plunge only a certain depth into the balloon material. By movingthe mask and repeating this process, the desired grouping ofindentations may be achieved.

Referring now to FIG. 13, there is illustrated yet another alternativeembodiment of a process in accordance with the methods of the presentinvention. As shown in FIG. 13 a mechanical tool, such as a grindingtool 50, can be configured to travel approximately perpendicular to theexpanded and fixed balloon surface, wherein the mechanical tool furtherincludes a pressure sensitive control feature, such as a spring 54, thatpermits travel of the cutting tool to only a certain depth. Once theresistance of the cutting surface becomes greater than the forcesupplied by the spring, then the cutting tool will not remove any morematerial.

In accordance with the present invention, the ablation may be performedthrough the use of a laser, such as but not limited to, an excimerlaser. For example, a wavelength between 100 and 500 nm may be utilizedto form the indentations within the tapered portion 15 of the balloon10. While other wavelengths (e.g. 248 nm, 308 nm) can yield satisfactoryresults, the wavelength of 193 nm is best suited for minimizing thermaleffects for ablation of a PET dilatation balloon. The fluence level atthe surface preferably is in the range of about 100-800 mJ/cm², and morepreferably is about 160 mJ/cm². The excimer laser beam is pulsed at arepetition rate in the range of about 10-50 pulses per second, with eachpulse lasting in the range of about 10-15 ns. Although specificwavelengths, fluence levels and pulse width are given above, theseshould not be considered limiting in any manner and should be consideredonly as examples.

Within the operable limits, the fluence, pulse repetition rate, pulseduration and the total number of pulses can be selectively varied tocontrol the nature of excimer laser energy ablation. The polymericballoon and catheter materials generally have high absorptivity, andthus limit the depth of energy penetration and material removal. Forexample, the PET balloon material can be removed in ultra thin layers onthe order of a micron or a fraction of a micron, depending largely uponthe selected fluence. Higher levels of fluence remove greaterthicknesses of material, but also tend to increase thermal effects.Pulse duration and pulse frequency can be increased to increase theamount of material removal, although again tending toward thermaleffects. Additionally, color may be introduced within or onto theballoon material in order to modify its absorption characteristics andconsequently the material removal rate.

Exposure of polymeric materials to laser energy is believed to havephoto-chemical and photo-thermal aspects. The former involves thebreaking of bonds and disassociation of molecules, leading to momentarypressure increases that eject material, with little or no thermaldamage. This effect may be accomplished using a large range of energywavelengths and laser sources. Photo-thermal effects are the result ofmolecular vibrational energy. The photo-thermal effects can be minimizedby minimizing the energy wavelength (i.e. selecting 193 nm) and byminimizing the fluence. As a result, material is removed essentiallywithout any substantial crystallizing, embrittling or other undesirablealtering of the remaining polymeric material. Further as a result oftreatment, the wetting characteristics of the polymeric material arechanged favorably, so that the surface is more hydrophilic and lessthrombogenic.

As described above, there are several approaches to removing materialfrom the tapered sections or sleeve sections of the balloon inaccordance with the present invention. Further, the balloon can besupported on a mandrel and inflated. Then, the excimer laser beam can beoriented to the tapered section or the sleeve section, wherein theablation proceeds in a stepwise process as the ablation occurs, themandrel and balloon are rotated, and the ablation occurs again. Thisprocess is repeated to create a uniform or non-uniform field ofindentations or cavities within the respective tapered or sleevesections of the balloon. Alternatively the balloon may be stationary,while the excimer laser beam is “rotated” with mirrors or other opticalcomponents. This process may also include the use of a mask to controlthe location that laser energy penetrates the balloon material. The useof masks can increase the efficiency of the material removal process.

Yet another alternative involves positioning the evacuated balloonagainst a plate in a flattened orientation, prior to its bonding to thecatheter. Then, the excimer laser beam can be traversed across thedesired balloon sections, incrementally creating indentations. This ispreferably accomplished through the use of a mask to control thelocation that laser energy penetrates the balloon material. Afterablation of one side, the balloon is turned over and the reverse side isablated.

The catheter shaft may also be ablated at other locations, e.g. at thedistal section or distal tip, the balloon sleeve that extends beyond thedistal cone of the dilatation balloon may be ablated. Ablatingindentations in the catheter can improve trackability in terms ofnegotiating sharp turns in vascular passages.

Alternatively, material may be selectively removed through the use ofdifferent laser sources. For examples, but not limited to, aphemto-second laser. Similar to the use of ablative excimer laser, thelaser itself or the work piece may be moved relative to the other. Bydoing this, and by controlling the activity of the laser, a plurality ofindentations can be formed in the balloon and catheter sections.

Indentations within the balloon and catheter sections or cavities withinthe sleeve sections of the balloon may also be achieved through the useof mechanical ablation methods. For example, processes such as drilling,milling, or grinding can be used to locally remove material in thedesired areas. There are several methods of using these types ofprocesses to achieve the goal of this invention. For example, a grindingor drilling tool may be pressed against the balloon or catheter whilethe tool is being rotated. The depth of material removal can bedetermined by displacement of the cutter or the cutting piece. The depthof material removal can also be determined by supporting either thecutter, and then pressing the tapered portion of the balloon pieceagainst the support piece using a pressure sensitive mechanism thatcontrols the depth of the indentation. The pressure sensitive mechanismcan be, for example, a spring or pneumatic cylinder that is adjusted toprovide a given depth of material removal. Additionally, using apressure sensitive mechanism, the time of contact may be varied tocontrol the depth of the indentation. Additionally, a cutting tool canextend a certain distance from the surface of a retaining feature. Theballoon may then be inflated or pressed against the retaining feature,thereby forming an indentation with a depth approximately equal to theextension distance of the cutting tool from the retaining featuresurface. A combination of these processes, or a process obvious to thoseskilled in the art, may also be used to create this invention.

Another means of creating the desired grouping of indentations orcavities is to deflate the balloon and secure it against a support, forexample a plate. Any of the variety of means for removing material suchas described above may then be employed to create the desired groupingof indentations.

In another aspect of the invention, the balloon can be fabricated from atubular member such as a polymer tubular member. In this manner, the atleast one cavity and/or the at least one indentation can be formed in asection of the tubular member that corresponds to the sleeve sectionsand/or the cone sections of a balloon when formed from the tubularmember. In this regard, predetermined sites of the tubular member whichcorrespond to the distal and proximal sleeve sections and/or the distaland proximal cone sections are determined. The at least one cavityand/or the at least one indentations is formed in the sleeve and/or conesections, respectively. Thereafter, the tubular member is processedaccording to methods known in the art to form a balloon having at leastone cavity formed in the proximal and/or distal sleeve sections. Ifdesired, the at least one indentation can be formed in the proximaland/or distal cone sections.

The balloon of the present invention may be disposed on different typesof shafts, or on multiple shafts. For example, the invention may includea balloon disposed on a fixed wire device.

In accordance with another aspect of the invention, a method for forminga compliant medical device is provided. The method comprises providing aballoon formed from polymeric material. A portion of polymeric materialis removed from the sleeve sections of the balloon to define at leastone cavity and preferably a plurality of cavities along a lengththereof, as discussed above. The balloon is configured about a cathetershaft, preferably the distal section of the catheter shaft. The balloonis secured to the catheter shaft by bonding the proximal and distalsleeve sections to the outer surface of the catheter shaft such thatduring the bonding step the polymeric material of the sleeve sectionsbecomes molten, for example by the application of heat or other energysource. The molten polymer flows into the cavities defined in the sleevesections to achieve a reduced profile bonding area.

The reduced profile bonding area is defined by at least a portion of theballoon polymeric material flowing into at least one cavity. The methodmay further include the step of removing a portion of material from thecone sections of the balloon to define indentations along a lengththereof as discussed above.

Those skilled in the art may recognize other equivalents to the specificembodiments described herein which equivalents are intended to beencompassed by the claims attached hereto.

1. A method for forming a compliant medical device, comprising:providing a balloon formed from polymeric material, the balloon having aproximal cone section, distal cone section, a medial section disposedtherebetween; a proximal sleeve section disposed proximal the proximalcone section and a distal sleeve section disposed distal the distal conesection, the proximal and distal sleeve sections each having a wall withan inner surface, an outer surface and a thickness defined therebetween;removing a portion of polymeric material from the inner surface of thewall of at least one of the proximal or distal sleeve section to a depthless than the thickness of the wall without penetrating the outersurface of the wall; positioning the balloon about a portion of acatheter shaft; bonding the at least one of the proximal or distalsleeve section to the portion of the catheter shaft to define a reducedprofile bonding area.
 2. The method of claim 1, wherein the polymericmaterial is removed from the wall of the proximal sleeve section.
 3. Themethod of claim 1, wherein the polymeric material is removed from thewall of the distal sleeve section.
 4. The method of claim 1, wherein thepolymeric material is removed from the wall of the proximal sleevesection and from the wall of the distal sleeve section.
 5. The method ofclaim 1, wherein removing the polymeric material includes milling thewall of the at least one of the proximal or distal sleeve section. 6.The method of claim 1, wherein removing the polymeric material includesat least one technique selected from the group consisting of laserablation, mechanical grinding, drilling, chemical or mechanical etchingand any combination thereof.
 7. The method of claim 1, wherein removingthe polymeric material includes cutting circumferentially about the atleast one of the proximal or distal sleeve section.
 8. The method ofclaim 1, wherein removing the polymeric material includes cuttingspirally about the at least one of the proximal or distal sleevesection.
 9. The method of claim 7, wherein the polymeric material isremoved at a generally constant depth from the inner surface along alength of the at least one of the proximal or distal sleeve section. 10.The method of claim 7, wherein the polymeric material is removed at avaried depth from the inner surface along a length of the at least oneof the proximal or distal sleeve section.
 11. The method of claim 1wherein the at least one of the proximal or distal sleeve sectionfurther includes an edge, and wherein the polymeric material is removedfrom the inner surface along a longitudinal length from the edge. 12.The method of claim 1, wherein the at least one of the proximal ordistal sleeve section has a length and wherein the polymeric material isremoved along the entire length.
 13. The method of claim 1, whereinbonding includes heat welding the at least one of the proximal anddistal sleeve section to the catheter shaft.
 14. The method of claim 1,wherein the catheter shaft includes an inner member and an outer memberand wherein bonding comprises bonding the proximal sleeve section to theouter member and the distal sleeve section to the inner member.
 15. Themethod of claim 1, further including removing a portion of polymericmaterial from the at least one of the proximal or distal cone sectionsto define at least one indentation along a length thereof.
 16. Themethod of claim 15, wherein the at least one of the proximal or distalcone section includes a wall having a first thickness, the medialsection includes a wall having a second thickness, and the at least oneindentation includes a depth extending into the wall of the proximal ordistal cone defines a third reduced thickness along a section of thewall of the at least one of the proximal or distal cone section.
 17. Themethod of claim 16, wherein the third reduced thickness is substantiallyequal to the second thickness.
 18. The method of claim 16, wherein thethird reduced thickness is greater than or equal to the secondthickness.
 19. The method of claim 15, wherein removing material fromthe at least one of the proximal or distal cone section is performed byat least one technique selected from the group consisting of laserablation, mechanical grinding, milling, blasting, drilling, chemical ormechanical etching and any combination thereof.